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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease

NCT ID: NCT05557864

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-25

Study Completion Date

2025-12-31

Brief Summary

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This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parkinson's disease with DBS

Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Pallidal Deep Brain Stimulation

Interventions

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Deep Brain Stimulation

Pallidal Deep Brain Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of idiopathic PD
* have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
* Existing 7T brain imagery

Exclusion Criteria

* history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
* other significant neurological disorder
* history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR)
* post-operative complications or adverse effects
Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Colum MacKinnon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colum MacKinnon, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Colum MacKinnon, PhD

Role: primary

Other Identifiers

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NEUR-2016-25128

Identifier Type: -

Identifier Source: org_study_id